LBE · Class I · 21 CFR 890.3850

FDA Product Code LBE: Stroller, Adaptive

Leading manufacturers include Columbia Medical Mfg, LLC and Ki Mobility, LLC.

8
Total
8
Cleared
80d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Stroller, Adaptive Devices (Product Code LBE)

8 devices
1–8 of 8
Cleared Aug 31, 2023
Little Wave Arc
K223533
Ki Mobility, LLC
Physical Medicine · 281d
Cleared Oct 16, 2013
PEDIATRIC FOLDING WHEELCHAIR
K130644
Columbia Medical Mfg, LLC
Physical Medicine · 219d

About Product Code LBE - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code LBE since 1978, with 8 receiving FDA clearance (average review time: 80 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.